Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 12:43 PM
Ignite Modification Date:
2025-12-24 @ 12:43 PM
NCT ID:
NCT07203261
Brief Summary:
The study compares the Body Roundness Index (BRI) and the A Body Shape Index (ABSI) with with body fat and visceral fat in people living with HIV.
Detailed Description:
Obesity is among the most prevalent cardiometabolic issues in recent years among people living with HIV (PLWH), and this is especially true among those that initiate and continue to take ART. Even newer first-line ART medications like Integrase inhibitors are strongly associated with the development of obesity among PLWH. This is of particular importance since research shows that excess fat, especially excess fat in the abdominal region, is associated with mortality (Jayedi et al., 2022; Lee et al., 2018). However, fat distribution in PLWH taking ART may not follow the same pattern of fat distribution found in general population (Lamesa et al., 2014). PLWH taking ART often experience abnormal accumulation of fat in the trunk and abdominal region (i.e., lipohypertrophy) and wasting of fat in the hips and extremities (i.e., lipoatrophy), both which can happen together or separately.
The Body Roundness Index (BRI) and A Body Shape Index (ABSI) are simple non- invasive anthropometric methods used to evaluate body fat distribution in general population. These measures can be very useful since they are predictive of overall body fat and visceral adipose tissue (VAT), and they correlate with diabetes, insulin resistance, metabolic syndrome among other cardiometabolic issues. Further, among PLWH, the ABSI and BRI have been associated with cardiovascular risk in men. However, the relationship between these anthropometric measures with overall body fat and VAT has not been evaluated among PLWH. The complex and unique nature of the fat distribution in PLWH taking ART warrants further evaluation of the validity of these measures in this patient population.
The study is cross-sectional in design and will be completed in one session. Participants living with HIV who agree to participate will be asked to complete a sociodemographic and health history questionnaire, and will then have their height, weight, waist circumference and hip circumference measured to calculate their BRI and ABSI. Participants will also have their body fat and lean body mass measured through air displacement plethysmography (ADP) and through bioelectrical impedance analysis (BIA). Visceral adiposity will be measured through ultra sound.
Study:
NCT07203261
Study Brief:
Protocol Section:
NCT07203261